Additional Effect of Steroid on Hyaluronic Acid in Subdeltoid Bursitis

Официальное название

Comparison of the Efficacy of Combined Hyaluronic Acid and Triamcinolone Acetonide Injection and Hyaluronic Acid Alone Injection in Patients With Subdeltoid Bursitis

Обзор

The study employs a double-blind, randomized clinical trial design with 60 patients diagnosed with subdeltoid bursitis. Participants are divided into two groups: the experimental group receives combined hyaluronic acid and Triamcinolone Acetonide injections, while the control group receives hyaluronic acid alone injection. All injections are guided by ultrasound. Assessments are conducted before treatment and at 1 week, 1 month, and 3 months post-treatment.

Подробное описание

Evaluation indicators include pain (measured by Visual Analog Scale for rest, activity, and sleep, and pain threshold via pressure algometer), function (assessed by Disabilities of the Arm, Shoulder, and Hand score and Shoulder Pain and Disability Index), quality of life (using the World Health Organization Quality of Life-BREF).

Вмешательства

• Препарат Hyaluronic acid injection
  traditional rehabilitation programs
• Препарат Triamcinolone Acetonide injection
  traditional rehabilitation programs

Первичные конечные точки

• Shoulder Pain and Disability Index [Срок оценки: Score change from baseline to 1 week, 1 months and 3 months of treatment, higher score, the better outcome]

Вторичные конечные точки (4)

• Disabilities of the Arm, Shoulder, and Hand [Срок оценки: Score change from baseline to 1 week, 1 months and 3 months of treatment, higher score, the better outcome]
• Score change from baseline to 1 week, 1 months and 3 months of treatment, higher score, the better outcome [Срок оценки: Score change from baseline to 1 week, 1 months and 3 months of treatment, higher score, the better outcome]
• World Health Organization Quality of Life [Срок оценки: Score change from baseline to 1 week, 1 months and 3 months of treatment, higher score, the better outcome]
• visual analog scale [Срок оценки: Score change from baseline to 1 week, 1 months and 3 months of treatment, higher score, the better outcome]

Критерии участия

Критерии включения

• \- Unilateral shoulder pain within the past 3 months

Pain during joint movements such as abduction or internal rotation

At least one positive result from the following tests: Painful arc, Neer test, or Hawkins test

No shoulder injections received in the past 3 months

Willingness to receive injection treatment and undergo follow-up assessments at the following time points:

Immediate (1 week after injection)

Short-term (1 month after injection)

Mid-term (3 months after injection)

Avoid use of anti-inflammatory painkillers during the study period as much as possible; if intolerable pain occurs, acetaminophen (provided by the researcher) will be used to relieve symptoms

Критерии исключения

• Presence of infectious disease, inflammation, rheumatoid arthritis, or fracture

History of malignancy

Previous shoulder surgery

Sensory deficits

Tendon rupture of the rotator cuff or biceps tendon

Neurological disorders causing hand weakness or affecting shoulder mobility (e.g., stroke, Parkinson's disease, brachial plexus injury, peripheral neuropathy)

Cognitive impairment preventing completion of questionnaires

Cervical radiculopathy

Diagnosed frozen shoulder (adhesive capsulitis)

Psychiatric disorders

Breastfeeding or pregnant women

Received shoulder injection within the past 3 months, including corticosteroids, hyaluronic acid, Platelet-rich plasma, or any prolotherapy solution

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06935877 · 2025SKHADR040

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗